hatch waxman act

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Also known as The Drug Price Competition and Patent Term Restoration ActEnacted in 1984Amended the Patent lawsAmended the Federal Food, Drug, and Cosmetic ActBefore 1962- new drug approved based on safety alone1962- Proof of efficacy made compulsory for marketing approval of a new drug (Kefauver-Harris Amendments)


There was no provision for patent term extension prior to enactment of the Hatch Waxman Act, to make up for the time lost out of the total patent term during the marketing approval processGeneric companies required to submit their own comprehensive NDACostly Time consumingIf drug was covered by patentTesting could not begin until patent expiredTo overcome the above problems an act was needed to promote generic companies

Introduction contd

Reducing the cost associated with the approval of a generic drugAllowing Early-Experimental-UseCompensating the branded drugs manufacturers for the time lost from the patent term because of the regulatory approval formalityMotivating the generic drug manufacturers

Objectives of the actHWA strives to strike a balance between the interests of branded drug manufacturers, generic drug manufacturers and the consumers

Creation of section 505(j)Section 505(j) established the ANDA approval processThe timing of an ANDA approval depends in part on patent protections for the innovator drugNDA must include any patent that claims the "drug" or a "method of using [the] drug" for which a claim of patent infringement could reasonably be assertedOn approval of NDA, FDA publishes patent information for drug in Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

Provisions of the act

FDA publishes patent information on approved drug products in the Orange BookAn NDA applicant must submit the following information for each patent:Patent no and date on which the patent will expireType of patent, i.e. drug, drug product, or method of useName of patent ownerThe name of an agent of the patent owner or applicantBrand drugs listed for generics to compare with their proposed products

Provisions of the actORANGE BOOK

When an applicant submits an ANDA to the FDA, the applicant must certify one of four things under section 505(j)(2)(A)(vii):that the required patent information relating to such patent has not been filed (Para I) ;that such patent has expired (Para II) ;that the patent will expire on a particular date (Para III);that such patent is invalid or will not be infringed by the drug, for which approval is being sought (Para IV Patent Challenge)

Provisions of the actFour Types of Patent Certifications



First applicant to submit a substantially complete ANDA (first-to-file)May be shared by multiple applicantsSubject to forfeiture

If patent owner or NDA holder sues the ANDA applicant for patent infringement within 45 days of receiving notice of the Paragraph IV certification Runs from date of notification or expiration of NCE exclusivityMay be lengthened or shortened by the court

INCENTIVES AND PROTECTION180 Day Market exclusivity30-month stay of FDA approval

Upon ANDA acceptance for filing, the applicant must notify the NDA holder and patent owner of the ANDA within 20 days. The notice must include a detailed statement of the factual and legal basis of the opinion of the applicant that the patent is invalid or will not be infringed

Upon notification, the NDA holder and patent owners have 45 days in which to initiate an action for patent infringement. If such an action is brought within 45 days, the ANDA is subject to a 30-month stay of FDA approval beginning on the date the notification letter was received


Anda approvals

Anda approval & Indian companies Source: http://www.business-standard.com/india/news/indian-pharma-remains-top-in-us-generics/420523/Indian companies bagged 33.17% or 139 of 419 original ANDA approvals from US FDA in 2010

The manufacture, use, or sale of a patented drug is not an act of infringement, to the extent it is necessary for the preparation and submission of an ANDAThe Hatch-Waxman Act provides under 35 U.S.C. 271(e)(1), generally that:It shall not be an act of infringement to make, use, or sell a patented invention solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.Exempt Acts of Patent Infringementfor FDA Approval



Automatic Injunction 1st successful Para IV filerNotice of generic competition A big head start on othersCan be worth $$ mn per day


Orange Book provides public notice of patentsAllows for resolution of patent disputes prior to generic entry30-month stay of FDA approval of generic drugsPatent Term Restoration Allows for Several Market Exclusivities: Data Exclusivity5 years for New Chemical Entity (NCE) Drug3 years for non-NCE DrugOrphan Drug (7 years)Pediatric (PEDS) (6 months)HATCH WAXMAN TRADE-OFFBENEFITS FOR BRANDED MANUFACTURERS

180-day market exclusivity for first successful challenger to Orange Book patent Allows generics to challenge Orange Book patents without risk of damagesSafe Harbor rule allows generics to perform bioequivalence and other testing relating to regulatory approval without risk of patent infringementHATCH WAXMAN TRADE-OFFBENEFITS FOR GENERIC MANUFACTURERSDr Reddys was the first Indian company to get the 180-day exclusivity for marketing Fluoxetine (Eli Lillys Prozac) 40 mg capsule in August 2001

TypesTerm New chemical entity5 yearsNew Clinical study3 yearsOrphan drug7 yearsPediatric exclusivity6 months180-day generic market exclusivity180 days

Non-patent exclusivity

Hatch-Waxman Act, 1984Granted: to drug products containing a New Chemical EntityBlocks: submission of 505(b)(2) or ANDALength: five years (or four years if para. IV)New chemical entity exclusivity

New Chemical Entity: a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the act

Active Moiety: the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substanceNew chemical entityDEFINITIONS

Federal Drug Administration Amendments Act, 2007(FDAAA) Under strict conditions, an enantiomer can qualify as a NCE:The single enantiomer has not been previously approved except in the approved racemic drugThe NDA includes full new clinical investigationsThe clinical studies were not used for the racemateThe enantiomer indication is not in the same therapeutic category as the racemateThree-year exclusivity available: e.g., Lexapro(escitalopram); Nexium (esomeprazole)NCE Exclusivity For Enantiomers

Hatch-Waxman Act, 1984Granted: for submission of results of new clinical studiesBlocks: approval of 505(b)(2) or ANDALength: three yearsNew clinical study exclusivity

Granted for submission of reports of new clinical investigations (other than biovailability studies) essential to the approval of the application [or the supplemental application] and conducted or sponsored by the applicant

Examples: new or changed formulations; salts; indications; dosing regimens; patient populations; OTC switches; or other label changes Opana ER (immediate release extended release) Caduet (atorvastatin/amlodipine combination)New clinical study exclusivity

Orphan Drug Act, 1983Granted: to drugs intended for treatment of a rare disease or condition Affects < 200,000 people in the U.S., or No reasonable expectation of recouping dev. costsBlocks: approval of 505(b)(1), (b)(2), or ANDA directed to the same drug, for same diseaseLength: seven yearsAdditional rewards: tax credits; grants; fees waivedOrphan Drug Exclusivity

Food and Drug Administration Modernization Act, 1997 (FDAMA)Granted: to applicants who successfully complete FDA-requested clinical trials of a drug in a pediatric populationBlocks: approval of 505(b)(2) or ANDALength: six months beyond any existing marketing or patent exclusivitygovt funding of pediatric studies if no exclusivityPediatric exclusivity

Hatch-Waxman Act, 1984Granted: to first ANDA applicant who submits a substantially complete ANDA containing a paragraph IV certification Substantially complete = sufficient to permit reviewBlocks: approval of subsequently-filed ANDA containing a paragraph IV certificationLength: 180 days, from commercial marketing Generic Drug Exclusivity

Medicare Modernization Act, 2003 (MMA)Six ways to forfeit:1. failure to market2. withdrawal of application3. amendment of certification4. failure to obtain tentative approval within 30 mos.5. improper agreement with another applicant, the listed drug application holder, or a patent owner6. expiration of all patents180-Day Exclusivity Forfeiture

Delay in generic entry

Both parties decide it is in their mutual best interests to settle via a significant payment from the patent owner/branded to the generic to keep the generic drug off the marketThe generic may make more money than by rushing to market the drugThe branded may also make more money by paying the generic to defer


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